{
  "url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-3/division-3.2/division-3.2.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-3/division-3.2/division-3.2.3.json",
  "legislation": "eur/2013/503",
  "legislation_title": "Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-503",
  "path": "annex/II/division/II/division/3/division/3.2/division/3.2.3",
  "kind": "division",
  "number": "3.2.3",
  "heading": "Food and feed safety in relation to intake",
  "text": "The applicant shall evaluate the data generated to estimate possible short-term and long-term risks to human or animal health associated with the consumption of genetically modified food or feed with respect to the expression of new proteins/metabolites, as well as significantly altered levels of original plant proteins/metabolites in genetically modified foods/feed. This evaluation shall include a thorough analysis of the relevance and limitations of each test as well as of the whole information.\nThe applicant shall consider the range of levels observed for the compounds known to occur in the conventional counterpart and in reference varieties. This variability may be caused by differences that are genotype-dependent, environmentally dependent, or caused by genotype x environment interactions. In addition, the range of levels observed in a broad spectrum of food and feed representative for the human and animal diet may be taken into account given that it reflects the levels of the specific compound to which consumers may be exposed.\nIf single constituents and/or whole genetically modified food and feed are found to induce adverse effects in specific studies, information on dose response relationships, threshold levels, delayed onset of adverse effects, risks for certain groups in the population, and use of uncertainty factors in extrapolation of animal data to humans shall be submitted.\nThe applicant shall consider data on the characteristics of the new compounds present in the genetically modified plant including potential biological effects in humans and animals. If the compounds have known adverse health effects and maximum levels for the presence of these compounds in the plant or its products were laid down in specific legislation, these maximum levels shall be taken into account. Otherwise, reference values for acceptable or tolerable levels of intake, such as the acceptable daily intake (ADI) or tolerable upper intake level (UL), shall be considered in relation to the anticipated intake. In cases where the compound has been safely consumed in food, the intake levels of consumers from a conventional diet shall be considered as safe.\nThe applicant shall evaluate the information on the effects of processing on the new compounds. Potential accumulation/depletion in food and feed products entering the human or animal diet shall be considered. The applicant shall also evaluate the relevance of differences resulting from chemical reactions known to occur under processing conditions.\nIn cases where more complex genetic modifications are produced, for example, via transfer of multiple genes in a single construct, retransformation of pre-existing genetically modified lines, and stacking of transformation events through conventional breeding of genetically modified parents, the applicant shall discuss strategies for the assessment of any risk(s) associated with possible interactions between the newly expressed proteins, new metabolites and original plant constituents. The assessment shall take into account all available information including the mode of action of the newly expressed proteins, the molecular and compositional/agronomical characteristics of the genetically modified plant, and the outcome of animal toxicity studies and feeding trials.\nThe applicant shall evaluate data obtained to assess the allergenic potential of newly expressed proteins in genetically modified plants with respect to introduction of new allergenic proteins into the food and feed plants, a possible provocation of allergic reactions of susceptible individuals, as well as information to demonstrate that the genetic modification does not cause unintended changes in the characteristics and/or levels of expression of endogenous allergenic proteins in the genetically modified food. In particular, the choice of the test models shall be justified with respect to specificity, predictability and validation status.\nWith respect to intake estimations of genetically modified foods, the applicant shall evaluate the applied methodologies with respect to uncertainties associated with the prediction of long-term intake. Specific attention shall be paid to those genetically modified plants which are aimed at modifying nutritional characteristics of the food and feed. For those genetically modified products, the requirement for post-market monitoring shall be discussed as a mechanism for determining actual changes to overall dietary intake patterns of the genetically modified food, to what extent this has occurred and whether or not the product induces known (side) effects or unexpected side effects. If the performance of post-market monitoring is deemed necessary, the reliability, sensitivity and specificity of the proposed methods shall be provided.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/3/division/3.2/division/3.2.3",
    "retrieved_at": "2026-11-01T14:48:39.117159+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}